Validation of the Thai Osteoporosis Foundation and Royal College of Orthopaedic Surgeons of Thailand Clinical Practice Guideline for bone mineral density measurement in postmenopausal women

AbstractObjectiveThe primary objective of this study was to determine the sensitivity, specificity, and predictive values of the Thai Osteoporosis Foundation (TOPF) and Royal College of Orthopaedic Surgeons of Thailand (RCOST) Clinical Practice Guideline for bone mineral density (BMD) measurement for the detection of postmenopausal osteoporosis. Its secondary objective was to find better indicators to detect postmenopausal osteoporosis.MethodsPostmenopausal women were enrolled in this study between June and December 2014. The clinical risk factors following TOPF and RCOST Clinical Practice Guideline for BMD measurement were collected. Bone mineral density was measured using dual energy X-ray absorptiometry.ResultsFour hundred postmenopausal women were enrolled in the study. The mean age of the studied population was 66.16 ± 6.04 years. Twenty-seven percent of the participants had either osteoporosis of the lumbar spine, femoral neck, or total hip, of which 13.3% had osteoporosis at the lumbar spine, 21.3% had osteoporosis at the femoral neck, and 2.5% had osteoporosis of the total hip. The sensitivity and specificity for detecting osteoporosis of the whole TOPF and RCOST guideline were 96.2% and 16.7%, 98.8% and 18.7%, 90.0% and 15.1%, and 97.2% and 19.5% at the lumbar spine, femoral neck, total hip, and any sites, respectively. Multiple logistic regression analysis revealed that only OSTA ≤−1, osteopenia on X-ray and low trauma fracture after age of 40 years were significant clinical risk factors in the detection of postmenopausal osteoporosis. The Receiver Operating Characteristics (ROC) curve was used to obtain the optimum probability value of osteoporosis at any sites which revealed that the probability value of 0.2222236 would have a sensitivity of 67% and specificity of 62% as the optimal cut point to detect osteoporosis. A simple flow diagram of “OSTA ≤−1”, “Osteopenia on X-ray” and “A history of low trauma fracture after age of 40 years” was developed as a better trade-off guideline for BMD measurement.ConclusionsThis study revealed that the TOPF and RCOST guideline for BMD measurement provided a high true positive rate of disease detection but with an expense of high false positive rate. The simple flow diagram was proposed as a more appropriate guideline for BMD measurement in postmenopausal women

Efficacy and safety of raloxifene 60 milligrams/day in postmenopausal Asian women

In healthy Caucasian postmenopausal women, raloxifene increases bone mineral density (BMD), decreases biochemical markers of bone turnover, and lowers low-density lipoprotein (LDL) cholesterol, without effects on high-density lipoprotein (HDL) cholesterol and triglycerides. This randomized, double-blind study examines the effects of raloxifene 60 mg/d (n = 483) or placebo (n = 485) in healthy postmenopausal Asian women (mean age 57 yr) from Australia, Hong Kong, India, Indonesia, Malaysia, Pakistan, Philippines, Singapore, Taiwan, and Thailand. Serum osteocalcin, serum N-telopeptide, total cholesterol, HDL cholesterol, LDL cholesterol, and triglycerides were assessed at baseline and 6 months. Lumbar spine BMD was measured at baseline and 1 yr in 309 women from 4 countries. Clinical adverse events were recorded at each interim visit. At 6 months, raloxifene 60 mg/d significantly decreased osteocalcin, N-telopeptide, total cholesterol, and LDL cholesterol by medians of 15.9%, 14.6%, 5.3%, and 7.7%, respectively, from placebo. Changes in HDL cholesterol and triglycerides were similar between raloxifene and placebo. Raloxifene 60 mg/d increased mean lumbar spine BMD (1.9%) from placebo at 1 yr (P = 0.0003). The incidences of hot flashes (placebo 3.5%, raloxifene 5.6%, P = 0.12), and leg cramps (placebo 2.7%, raloxifene 4.3%, P = 0.16) were not different between groups. No case of venous thromboembolism was reported. The effects of raloxifene 60 mg/d on bone turnover, BMD, and serum lipids in healthy postmenopausal Asian women were similar to that previously reported in Caucasian women.Annie W. C. Kung, Hsiang-Tai Chao, Ko-En Huang, Allan G. Need, Nimit Taechakraichana, Foo-Hoe Loh, Florante Gonzaga, Usha Sriram, Nik Mohd Nasri Ismail, Abid Farooqi, Ichramsjah Azim Rachman, Gerald G. Crans, Mayme Wong and Daniel Thiebau